The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis

March 19, 2018 updated by: Burcu Talu, Inonu University

Assessment Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis

This study was planned to evaluate the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis aged 35-65 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The degeneration that occurs in the osteoarthritis of the knee joint leads to the loss of proprioception, resulting in the misalignment of the mechanoreceptors in that region, the joint stabilization is impaired, the muscles do not fulfill the protective role and the joint neuromuscular is inadequate for control. Neuromuscular control is the subcortical activity of effector structures against stimulation with mechanoreceptor, visual, and vestibular affinities. Proprioception, kinesthesia, sensation of joint position, visual and vestibular information constitute sensory data; functional motor patterns, dynamic joint stability and reactive neuromuscular control motor efferent response definitions. Disturbance of neuromuscular control of the muscles also affects walking and balance with abnormal weight transfer. There are many ways to treat knee osteoarthritis such as patient education, weight control, different physical therapy modalities (hot, cold, electrotherapy, deep heat), exercise, pharmacological treatments (topical, systemic, intraarticular). There is no radical treatment of osteoarthritis to restore structural changes; but with the treatment applied, findings such as pain and loss of function of the individual can be reduced and the patients become more independent in daily life activities. Surgical treatment is the last resort in osteoarthritis. In osteoarthritis( OA), there is no pharmacological method to treat the deformed joint structure that will change the course of the disease. This situation significantly increases the importance of rehabilitation in the treatment of osteoarthritis. The aim of neuromuscular rehabilitation that reestablish and regulated features such as dynamic joint stability, reactive neuromuscular control, functional motor patterns. Rehabilitation programs created for this purpose include balance exercises, strengthening exercises, postural control, functional exercises, postural orientation, flexibility, agility, plyometric exercises, spore-specific exercises. neuromuscular exercise program includes 7 parameters including functional mobility, functional stability, sensorimotor system training, proprioceptive neuromuscular facilitation training techniques, plyometric exercises, reactive neuromuscular system training, technical training. Main purpose of this study is that the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44100
        • Malatya Gozde Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with knee osteoarthritis,
  • individuals without a physical disability,
  • person in an age range 35- 65 years,
  • Having no any knee surgeon,
  • Mentally that is sufficient to make assessments,
  • Who want to be involved voluntary work,
  • Ability to adjust the training program
  • Individuals who received informed consent

Exclusion Criteria:

  • Individuals who do not allow mental evaluation
  • Individuals who do not want to be involved in voluntary work.
  • Clinical study refused to participate in.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neuromuscular Exercises Group
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and neuromuscular exercises training
Behavioral: Neuromuscular Exercises
In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations. The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control. NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.
Active Comparator: Conventional Group
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and conventional exercises.
Behavioral: Conventional Group
In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks

The scale used to measure knee function (0-100 total score). High scores indicate poor function status and low scores indicate good function status. The scale contains 24 questions, three subgroups of pain, stiffness and physical function.

There are 5 alternative answers to the questions: 0 = no, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The rating (total of all answers / 96) was calculated as * 100.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
It used to measure level of pain (0-100 mm). On a horizontal line of 100 millimeters (mm), the initial 0 (no pain) and end (pain at unbearable grade) were marked. It was requested to place a mark on this horizontal line according to the degree of pain they felt in the cases. The point marked on the line was then recorded as a VAS value in mm, measured by a ruler.
6 weeks
Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
It used to measure level of physical activity. IPAQ short form; 7 questions that provide information about time spent on walking, moderate to severe activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute score. Standard MET values for these activities are: Walk = 3,3 MET; Moderate Severe Physical Activity = 4,0 MET; Severe Physical Activity = 8.0 MET; Seating = 1,5 MET.
6 weeks
Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
It used to measure static balance.Anterior (A), Posteromedial (PM) and posterolateral (PL) measurements were performed. It was glued to three graves at 120 degrees. The patient was asked to put one foot on the intersection of these three bombers and to lie in directions A, PM, and PL with the other foot. During the test, the patient was asked to point to the maximum point he could reach without touching his foot and to bring it to the stable foot without losing balance. The distance is measured in centimeters.
6 weeks
Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks

It used to measure functionality.

The questionnaire consists of 10 questions in total. 0 is the worst level of activity when measuring activity level; 4 is answered for the maximum level of activity. Similarly, when evaluating frequency, 0 is the most severe, 10 is not. 0-100 total score.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Burcu Talu, PhD, Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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